All documents shown here are included in the seminar for instant download

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for
instant download. All reference material as listed below and more is
available on a special seminar website. The website is regularly
updated with most recent information. In case there are questions
related to the topic, they can be submitted through a web form and
will be answered by the speaker. For ordering info
click here.

On-line Audio Seminar 145

Network Infrastructure Qualification

Understanding the New GAMP/ISPE and FDA
Guides

Recorded

Federal laws and regulations mandate to put controls and measures on a company
network to ensure security and data integrity. Examples are 21 CFR Part 11,
Sarbanes-Oxley Act, and HIPAA. With this new legislation network qualification
and compliance become a much more recognizable issue at higher levels of
management. This was recognized by the FDA and industry organization and
institutes such as GAMP/ISPE and the Institute of Validation and Technology
(IVT). The FDA published a guide on Cybersecurity for Networked Medical Devices,
GAMP/ISPE released a Good Practices Guide on IT Infrastructure Control and
Compliance and IVT proposed a standard for Network Infrastructure Qualification.
With FDA's new focus on computer validation and IT systems, industry is looking
for advice on how to implement the guides.

Questions related to network qualification:

What does network compliance mean?

Is there an official guidelines from the FDA?

What do inspectors ask and what do they want to see?

What does the approach of the GAMP/ISPE Good Practices
Guide?

What does the approach of the IVT proposed standard?

Should networks comply with 21 CFR Part 11?

What about other legislation such as Sarbanes-Oxley and
HIPAA?

We validate the application running on the network, so we
know that it works, why should we qualify the infrastructure?

How much testing is enough: should we test each network
component, like switches, routers and servers?

How to verify integrity of file transmission?

I have multiple clients with the same configuration, should
I qualify/validate all of them?

We have an existing network, where and how should we start?

How to deal with security patches?

Our network changes so often, how can I keep it in a
validated state?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new
interactive audio seminar. During the seminar, the speaker will
present strategies and give practical recommendations. After the
seminar, an extensive list of reference material like SOPs,
templates and examples will help immediate and cost effective
implementation.

How to order

About audio seminars

Online audio seminars are presented over the
phone. During the live presentation attendees can:

Study the printed slide material

Watch the slides on a computer

Watch the slides on a video screen in a seminar room

Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
agencies.

Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,
click here.